Angiomax/Angiox (Bivalirudin) Reduced Cardiac Mortality by 44%; Reduced Overall Mortality by 25% in Severe Heart Attack Patients Following Angioplasty
HORIZONS-AMI Trial Three-Year Results Presented at TCT
WASHINGTON, DC, Sep 25, 2010 (MARKETWIRE via COMTEX) --Cardiology researchers today reported that severe heart attack patients were more likely to survive three years after emergency angioplasty if they were administered the right medicines on the day of the procedure.
"The results at 3 years, representing the final report from the HORIZONS-AMI trial, are consistent with and extend the 2-year data that we reported last year at TCT," said Gregg W. Stone, MD, Professor of Medicine at Columbia University College of Physicians and Surgeons, Director of Cardiovascular Research and Education at the Center for Interventional Vascular therapy at New York-Presbyterian Hospital/Columbia University Medical Center and Co-Director of the Medical Research and Education Division at the Cardiovascular Research Foundation. Dr. Stone is the principal investigator of the HORIZONS-AMI trial.
"The data demonstrate that use of bivalirudin alone, as opposed to a combination of heparin and a GP IIb/IIIa inhibitor, can save lives," Dr. Stone said. "In addition, a significant reduction in second heart attacks has emerged over time in patients treated with bivalirudin."
Dr. Stone presented the late-breaking findings here at the 22nd Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference scientific symposium sponsored by the Cardiovascular Research Foundation.
HORIZONS-AMI showed that patients were significantly less likely to suffer cardiac death and had better overall survival if treated with Angiomax(R) (bivalirudin) while undergoing angioplasty, compared with those treated with heparin plus a platelet glycoprotein IIb/IIIa inhibitor (GPI) during angioplasty. Results at 30-days, one year and two years post angioplasty follow up have previously been published and/or presented by medical peer review publications or at congresses.
The Medicines Company (NASDAQ: MDCO), a clinical trial co-sponsor, today announced the presentation. "The HORIZONS-AMI trial demonstrates a commitment by The Medicines Company to continued innovation with Angiomax," said Clive Meanwell, President and Chief Executive Officer of The Medicines Company. "This trial was a major commitment by many -- led by the team at CRF. We believe the results will continue driving life-saving innovation in the hospitals we serve all over the world. We are excited with the growth potential these results are planned to generate."
HORIZONS-AMI is the first trial of pharmacologic therapy to demonstrate a mortality benefit in STEMI patients undergoing PCI. The trial compared Angiomax vs. unfractionated heparin (UFH) plus glycoprotein IIb/IIIa Inhibitors (GPI) in 3,602 patients presenting with STEMI undergoing a primary PCI strategy. Results at three years showed Angiomax:
-- Significantly reduced the incidence of cardiac-related death
percent (2.9% vs. 5.1%, HR 0.56 [95% CI 0.40-0.80]; p equals 0.001),
-- Significantly reduced all-cause death by 25 percent (5.9% vs. 7.7%, HR
0.75 [95% CI 0.58-0.97]; p equals 0.03),
-- Significantly reduced the incidence of reinfarction by 23 percent
(6.2% vs. 8.2%, HR 0.76 [95% CI 0.59-0.92]; p equals 0.04),
-- Significantly reduced rates of major bleeding by 36 percent (6.9% vs.
10.5%, HR 0.64 [95% CI 0.51-0.80]); p less than 0.001),
-- Demonstrated no difference in rates of major adverse cardiac events
(17.3% vs. 17.8%, p equals 0.65),
-- Demonstrated comparable rates of stent thrombosis (4.5% vs. 5.1%, HR
0.89 [95% CI 0.65-1.23]; p equals 0.49).
About the HORIZONS-AMI Trial
HORIZONS-AMI, co-funded by a grant from The Medicines Company, is the largest study to focus on the appropriate use of anticoagulation medications and stents in patients experiencing STEMI and undergoing primary percutaneous coronary intervention (PCI), commonly known as angioplasty. This landmark trial was a prospective, single-blind, randomized, multi-center study conducted in 11 countries. Patients undergoing angioplasty were randomly assigned to receive either Angiomax (bivalirudin) with provisional use of GPI or heparin plus GPI. Patients enrolled in the HORIZONS-AMI trial also were assigned randomly to receive either TAXUS(R) drug-eluting stents or a bare-metal stent.
The two primary endpoints of the trial were major bleeding and net adverse clinical events, a composite of major adverse cardiovascular events (death, reinfarction, stroke or ischemic target vessel revascularization) and major bleeding at 30 days. The major secondary endpoint was major adverse cardiovascular events at 30 days.
About ST-Segment Elevation Myocardial Infarction (STEMI)
STEMI is the most severe type of heart attack and carries a substantial risk of death and disability. STEMI involves myocardial injury, indicated by significant abnormalities on electrocardiogram called ST-segment elevations. Guidelines recommend that STEMI patients be treated with rapid intervention to help prevent further heart damage. According to the American Heart Association, an estimated 865,000 new and recurrent heart attacks occur every year, of which 400,000 are categorized as STEMI.
STEMI is part of a spectrum of acute coronary syndromes (ACS) caused by acute exacerbation of underlying coronary artery disease. ACS also includes non-ST elevation myocardial infarction (NSTEMI) and unstable angina (UA). NSTEMI is typically caused by partial obstruction of a coronary artery that results in some damage to heart muscle. UA is chest pain at rest or upon exertion, due to ischemia. Stable angina is characterized by predictable chest pain during exertion that resolves at rest, and is not considered a form of ACS. Each year in the United States, about 5 million people present to the emergency department with chest pain, of which an estimated 1.4 million are identified with ACS. In Europe, more than 1 million PCIs are performed annually of which in excess of 200,000 are primary PCIs for patients with STEMI.
About bivalirudin (Angiomax/Angiox)
Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action and a 25 minute half-life. In clinical trials, treatment with Angiomax resulted in improved clinical outcomes with significantly reduced rates of major bleeding compared to treatment with heparin plus GPI across the entire spectrum of risk in patients undergoing PCI and numerically lower rates of one-year mortality in patients undergoing PCI.
In the United States, Angiomax with provisional GPI is indicated in patients undergoing angioplasty, also called PCI, and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. The most common adverse events for Angiomax in clinical trials comparing Angiomax and heparin were back pain, pain, nausea, headache and hypotension. The incidence of these adverse events was comparable in both the Angiomax and heparin groups in these trials. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components. Angiomax is not approved for use in ACS patients not undergoing PCI. Please see full prescribing information available at http://www.angiomax.com.
Angiox is the trade name for bivalirudin in the European Union. In Europe, Angiox currently is indicated as an anticoagulant for adult patients undergoing PCI, including patients with STEMI undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina/non-ST segment elevation MI planned for urgent or early intervention. Angiox should be administered with aspirin and clopidogrel. Please see full prescribing information available at http://www.angiox.com.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients. The Medicines Company's website is www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "plans" and "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether physicians, patients and other key decision-makers will accept clinical trial results, whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians, patients and other key decision-makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on August 9, 2010, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The Medicines Company
Phone: (973) 290-6000
Posted: September 2010